To place your order, please contact your wholesaler OR Cipla USA at 844-CIPLA US (844-247-5287)

INDICATIONS 1
Paclitaxel is a microtubule inhibitor indicated for the treatment of:

• Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
• Locally advanced or metastatic non-small cell lung cancer (NSCLC), as firstline treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
• Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

IMPORTANT SAFETY INFORMATION
BOXED WARNING: SEVERE MYELOSUPPRESSION

• Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3.
• Monitor for neutropenia, which may be severe and result in infection or sepsis.
• Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound).

CONTRAINDICATIONS
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with:

• Baseline neutrophil counts of < 1,500 cells/mm3
• A history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound)

WARNINGS AND PRECAUTIONS
Severe Neuropathy
occurs frequently and may require dose reduction or treatment interruption.
Sepsis
occurred in patients with or without neutropenia who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; interrupt paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1,500 cells/mm 3, then resume treatment at reduced dose levels.
Pneumonitis
occurred with the use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; permanently discontinue treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine.
Severe Hypersensitivity
Reactions with fatal outcome have been reported. Do not rechallenge with this drug.
Use in patients with hepatic impairment
Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment, consider dose reduction and closely monitor patients with hepatic impairment.
Albumin
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) contains albumin derived from human blood, which has a theoretical risk of viral transmission.
Embryo-Fetal Toxicity
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

DRUG INTERACTIONS
Use caution when concomitantly administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) with inhibitors or inducers of either CYP2C8 or CYP3A4.

DOSAGE AND ADMINISTRATION
Do not substitute paclitaxel protein-bound particles for injectable suspension (albumin-bound) for other paclitaxel products.

ADVERSE REACTIONS

• The most common adverse reactions (≥ 20%) in metastatic breast cancer are alopecia, neutropenia, sensory
  neuropathy, abnormal ECG, fatigue/asthenia, myalgia/ arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea.
• The most common adverse reactions (≥ 20%) in NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
• The most common (≥ 20%) adverse reactions of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in adenocarcinoma of the pancreas are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration.

You may report side effects to Cipla at 1-866-604-3268. You may also report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.